New coronavirus treatment approved by FDA

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Some slightly good news came out today that the FDA has approved emergency use authorization of convalescent plasma to treat Covid-19, after finding “known and potential benefits of the product outweigh the known and potential risks of the product.”

The FDA stated that more than 70,000 patients had been treated with convalescent plasma which is made from the blood of people who have already recovered from coronavirus infections.

“Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,” President Trump said at a White House briefing.

“Today’s action will dramatically increase access to this treatment.”

The authorization was somewhat controversial as there was apparently resistance from a group of federal health officials — including National Institutes of Health Director Dr. Francis Collins, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci and Dr. H. Clifford Lane, NIAID deputy director.

They reportedly claimed that the evidence was too weak to authorize the treatment.

But the FDA’s deputy commissioner came back out and said that the NIH was out of line for its remarks.

“In general, NIH is not involved in the decision-making process at the FDA and does not have the entirety of confidential data the FDA uses to make these regulatory decisions.”

“We take seriously our mandate to follow the data and science on the review of medical products to prevent or treat COVID-19 based on the agency’s established legal and regulatory standards.”

It’s encouraging news to see a treatment to get approval and to know that it has been used to treat more than 70,000 coronavirus patients.

But convalescent plasma is in limited supply and so there may be supply issues going forward. There are also limitations due to issues like blood type matches.

Also, there still needs to be randomized clinical trial data that needs to be confirmed but some of those trials are currently underway.

Hopefully, this is just the beginning of new treatments and soon vaccines that we will be hearing more positive news about in the next month or two.

H/T

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